·Training
opportunities: Pharmaceutical
Cooperation/Scheme PIC/S provides a forum for the training of
GMP inspectors thus allowing the latter to benefit from increased
training opportunities by attending PIC/S Seminars and Expert
Circles and by participating in the APSO Joint Visits Programmed. In
this respect, APSO is unique as there is no other international
training forum run jointly by Regulatory Authorities (individually,
Regulatory Authorities or organizations such as WHO or the EMEA
provide basic training courses, mainly to new inspectors). .

·International
GMP harmonization: By taking part in the meetings of the
APSO Committee, APSO Participating Authorities are involved in the
development and harmonization of international GMP guides and
guidelines. The APSO Committee also actively promotes the uniform
interpretation of GMP and Quality Systems for GMP Inspectorates.

Networking: By attending APSO activities, participants
benefit from personal contacts with other agencies, whether they are
part of APSO or not. This networking often simplifies contacts and
the exchange of GMP related information. In addition, APSO is one of
the few international GMP fora for networking and confidence
building amongst regulatory inspectors where experts (GMP
inspectors, specialist GMP inspectors and chief inspectors) can
meet, discuss issues of mutual concern and share experiences and
information. In other fora, participation is either at the level of
Heads of Agencies (e.g. WHO) or at the level of experts in a
particular field International Conference on Harmonization (ICH).

·High
standards: APSO ensures that all Members comply with
APSO standards at all times (assessment of new applicants and
reassessment of existing member inspectorates). Preparing for the
accession to the Scheme (or reassessment) forces improvements in the
GMP inspection system and procedures. This results in increased
efficiency of the GMP inspectorate. This is particularly true for
Quality System requirements, where APSO standards are high, and for
GMP training, which is essential in APSO

·Sharing
of information: APSO allows for a more effective use of
inspection resources through the voluntary sharing of GMP
inspections reports. Membership is also a cost-saving measure for
the inspection authorities confronted with an increase of
inspections, notably in the field of Active pharmaceutical
ingredients (APIs).

·Rapid
Alert System: Through APSO membership, Regulatory
Authorities automatically benefit from being part of the APSO Rapid
Alert and Recall System arising from quality defects of batches of
medicinal products, which have been distributed on the market. The
APSO alert and recall system is part of a wider system, which
includes the alert and recall system of EU/EEA/MRA partners.

·Facilitating
the conclusion of other Agreements: Membership in APSO
may also facilitate the conclusion of other agreements, e.g. Mutual
Recognition Agreements, between Members at various levels During the
recently concluded initial negotiation on GMP Inspection, APSO
membership accession was accepted as one of the essential criteria
for MRA.

There are also indirect
benefits to industry when their relevant regulatory authority
becomes a member of APSO. These benefits may include the following:

·Reduced
duplication of inspections

·Cost savings

·Export
facilitation

·Enhanced market
access

Although APSO is not a trade
agreement, membership in APSO may facilitate the export of
pharmaceuticals. Some non-PIC/S Authorities in e.g.
Colombia
and
South Africa
accept GMP certificates from PIC/S Participating Authorities.
Reputable organizations such as the “Global Fund to Fight AIDS,
Tuberculosis and Malaria ”consider PIC/S Participating Authorities
as “stringent Regulatory Authorities ”meaning that a medicinal
product may be pre-qualified by the Global Fund if it has been
authorized by a PIC/S Participating Authority. This means that non-PIC/S
authorities and organizations have a greater confidence in medicines
manufactured in countries where the Regulatory Authority is a PIC/S
Participating Authority. Consequently, the pharmaceutical industry
located in these countries indirectly benefits from PIC/S
membership."